very early medication abortion (
TRANSCRIPT
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Very early medication abortion(<6 weeks gestation)
Alisa B. Goldberg, MD, MPHAssociate Professor of Obstetrics & Gynecology
Harvard Medical SchoolDirector, Division of Family Planning & Family Planning Fellowship
Brigham and Women’s HospitalVice President, Research and Clinical Training,
Planned Parenthood League of MA
FIAPAC, Nantes September 14, 2018
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Case• 30 y.o. G2P1 with regular cycles, 3 days late for menses
• Two home urine pregnancy tests, both positive
• Calls clinic to schedule a medication abortion ASAP
• Appointment booked for 3 days later – 4 weeks 6 days LMP (= 34 days amenorrhea)
• Upon presentation she is asymptomatic and pelvic ultrasound reveals no gestational sac
• Urine pregnancy test is positive
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OBJECTIVES• Understand risks and benefits of offering medication
abortion very early in pregnancy (<6 wks)– Including with pregnancy of unknown location (PUL)
• Gain familiarity with protocols for offering medication abortion for women with PUL
• Review data for follow-up with serial hcg testing
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Abortion shifting earlier in gestation
• U.S. 20061
– 27% of all first trimester abortions < 6 weeks
• U.S. 20142
– 41% of all first trimester abortions < 6 weeks
1 Pazol et.al., CDC MMWR 2009 (2006 data)2 Jatlaoui et.al., CDC MMWR 2017 (2014 data)
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Medication abortion is increasingThe percentage of abortions completed with mifepristone and misoprostol has increased steadily over time
US: Jones and Jerman 2017, Guttmacher Institute (2014 data)UK: Dept of Health and Social Care; abortion statistics 2017
France: http://drees.solidarites-sante.gouv.fr/IMG/pdf/er_1013.pdfSweden: Socialstyrelsen.se, through 2017
Percentage of early abortions (< 8-10wks) by medication abortion
2006-2008 2014-2017
U.S. 17% (2008) 43% (2014)U.K. 43% (2007) 80% (2017)France 48% (2006) 64% (2016)Sweden 83% (2008) 95% (2017)
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Medical abortion protocol in U.S.March 2016 FDA updated label
• ≤ 70 days gestation
• Mifepristone 200 mg PO dispensed in-person
• Misoprostol 800 mcg buccally 24- 48h later at home
• Follow-up with healthcare provider in 7-14 days– To ensure pregnancy has passed and patient is well
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Efficacy of medication abortion with mifepristone + buccal misoprostol
Gestational duration Efficacy Ongoing pregnancy
49 days or less (N=12,555) 98.1 (97.9-98.3) 0.4 (0.3-0.5)
50-56 days (N=4161) 96.7 (96.1-97.2) 0.8 (0.6-1.2)
57-63 days (N=2202) 95.2 (94.2-96.0) 1.8 (1.3-2.5)
64-70 days (N=332) 93.1 (89.6-95.5) 2.9 (1.4-5.7)
Chen, Creinin, Obstet Gynecol 2015
Systematic review: 20 studies, N=33,846 womenMifepristone: 200 mg, Misoprostol: mostly 800 mcg
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Efficacy of medical abortion at <6 weeks gestation
• Systematic review comparing efficacy of medical abortion <42 days to 42-49 days– <42 days (N=5938, collectively)
• No difference in efficacy between groups– 6 RCTs: OR 0.51 (0.21-1.27)– 9 prospective observational: OR 0.90 (0.60-1.33)
• Unable to separately evaluate <35 days, or no gestational sac
Kapp, Baldwin, Rodriguez, Contraception 2018
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What is different at < 6 weeks?
Difficulty with diagnosis
Often cannot definitively diagnose intrauterine pregnancy (IUP), early
pregnancy loss (EPL) or ectopic pregnancy
Close follow-up required
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Potential benefits of offering medication abortion without definitive dx of IUP
• Eliminate delays in treatment– Reduce repeat visits to clinic
• Increase patient satisfaction– Get their desired abortion upon presentation
• Facilitate earlier diagnosis– Intrauterine pregnancy vs. ectopic
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Potential risks of offering medication abortion without definitive dx of IUP
• Missed or delayed diagnosis of ectopic**– If patient does not adhere to follow-up
• Over-treatment– Chemical pregnancies and some early pregnancy loss
(EPL)
• Expense – For women
• Abortion often out-of-pocket expense
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Diagnosing intrauterine pregnancyEarlier presentation for abortion, increased
likelihood of not visualizing IUP on sono
Gestational ageExpected markers of intrauterine pregnancy on transvaginal ultrasound
4.5-5.0 wks Gestational sac (GS), 2-3 mmIntradecidual sign
- eccentrically located GSDouble decidua
5.0-5.5 wks GS, yolk sac (YS)-YS initially seen as 2 parallel lines-YS seen by 8-10 mm GS
6.0 wks GS, YS, fetal pole (CRL)6.0-6.5 wks GS, YS, CRL, fetal heart tones
(FHT), FHT early as 1-4 mm CRL
Rodgers et.al. Radiographics 2015
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Medical abortion without a yolk sac • Retrospective study (N=1155)
– After protocol change in 2011
• Women presenting for MAB at <6 wks• Allowed to proceed with MAB without yolk sac if
– LMP < 6 wks– Eccentrically placed GS > 3 mm with decidual reaction – No signs or sx of ectopic (bleeding, pain)– No ectopic risk factors (sterilization, tubal surgery, prior ectopic)
Results– 1030 (89%) had yolk sac (IUP)
Heller and Cameron. J Fam Plann Reprod Health Care 2015
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Medical abortion without a yolk sac Results for women without definitive IUP
– 87 (7.5%) met criteria for MAB w/o YS• 76% same-day MAB, 24% had additional testing first• No ectopics, all had successful MAB
– 16 (1.4%) had empty uterus (1 ectopic, 0.08%)• Not eligible for same-day MAB• 15 with PUL had additional testing, IUP and eventual MAB
– 17 (1.5%) had sac, but did not meet criteria (no ectopics)• 9 (53%) had immediate MAB• 8 (47%) had additional testing, IUP and eventual MAB
– 5 (0.4%) definitive EPLà treated medicallyHeller and Cameron. J Fam Plann Reprod Health Care 2015
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Medical abortion in the setting of PUL (no gestational sac)
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Li study #1• RCT to evaluate lower dose mifepristone• 2500 women (LMP<35 days)
– Baseline serum hcg and vaginal ultrasound • Thickened stripe or small GS
– 5 arms, doses from 50-150 mg mifepristone– 24 h later 200 mcg oral misoprostol, in hospital– Observed 6h in hospital, expelled tissueàpathology
• If tissue confirmed: weekly hcg + sono (50% drop + ut. empty)• If no tissue confirmed, return in 3 days for hcg + sono• If no decline by 50%, repeat hcg and sono Q3 days• All followed until next menses
Li et.al. Reprod Sciences 2015
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Li study #1 (con’t)
• Results– Mean days of amenorrhea = 31 + 2– Baseline serum hcg 620-756– Endometrial thickness 1.17-1.22 cm– Complete abortion rates 97-98%
• No differnce by mife dose– No suspected or confirmed ectopics
Li et.al. Reprod Sciences 2015
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Li study #2• RCT, N=744
– <35 days LMP, elevated serum hcg, thickened stripe– 75 mg mife, 24h later 400 oral misoprostol– Hospital vs. home misoprostol
• Hospital follow-up (same as Li #1)• Home follow-up, urine hcg testing
– 24 h, 1 week, 2 weeks (phone calls)
• Results– 29% had discernible GS, EM thickness 1.2 cm– Complete abortion 98% both groups– 99% follow-up both groups– All with complete abortions had (-) UPT by week 2– 3 suspected ectopics (0.4%) - not confirmed, no treatment reported
Li et.al. Reprod Sciences 2017
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Planned Parenthood protocol(PPLM affiliate protocol, PPFA standards)
Medication abortion in setting of PUL is permitted when patient is low-risk for ectopic and when combined with close follow-up to exclude ectopic pregnancy
Eligibility Criteria– < 35 days LMP– Positive urine hcg– Asymptomatic (no bleeding, no pain)
– No ectopic risk factors (tubal surgery, IUD in situ, prior ectopic)
– Able and willing to comply with close follow-up
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PPLM protocol• Clinical management
– Initiate same-day medical abortion– Serum hcg sent on day of mifepristone
• Results return after patient has left clinic
– Management based on hcg• hCG <2000: proceed as planned. Repeat serum hcg 48-72
hours after misoprostol (day 3-5 after mife)• hCG 2000-2999: formal diagnostic ultrasound on day hcg
results received, or aspirate, or send to ER
• hCG >3000: or formal ultrasound-no IUP send to ER
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Planned Parenthood protocol (con’t)
• hCG follow-up– If hcg drops > 50% 3-5 days after
mifepristone, no additional follow-up required
– If hcg drops < 50%, evaluate for continuing pregnancy or ectopic
NAF (National Abortion Federation)Protocol very similar
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Serial hCG follow-up after medical abortion
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Ultrasound vs. serum β-hCG• N=217, <49 days preg• All had pre and post med ab sono and serum β-hCG• Follow-up day 6-18• 2 ongoing pregnancies, 2 retained sacs• Ongoing pregs: serum β-hCG increased
20% of initial value = 99.5% PPV for expulsion• This is where 80% drop at 1 week f/u rule came from*
Fiala et.al., Eur J Obstet Gynecol 2003
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Ultrasound vs. serum β-hCG • RCT (N=376)• Ultrasound vs. serum hCG med ab follow-up• Primary outcome: additional intervention beyond one
scheduled ultrasound or hCG. – Suction curettage, additional miso, visits (clinic, ED), testing
Results- 151 ultrasound, 159 hCG by 2 wks
• More loss to follow-up with ultrasound (19 vs. 11% p=0.04)- No difference in unplanned interventions:
– Any: 7% ultrasound vs. 8% β-hCG (p=0.6)– D&C: 4% ultrasound vs. 1% β-hCG (p=0.16)
Dayananda, Goldberg et.al. Obstet Gynecol 2013
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Serum hCG decline early daysafter medical abortion
Fig. 2. Decrease in serum hCG from Day 1 among women with complete abortion, n=57.
Pocius, Goldberg, et al. Contraception 2017
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Serum hCG decline after medical abortion
Day(s) after mifepristone
N Decrease in hCG from Day 1
(mean + SD)
Range
3 55 70.0 +10.6% 36.9-98.6%
5 49 91.4 +4.4% 68.4-97.7%
7-9 18 97.1 +1.7% 92.4-99.2%
10-11 11 98.5 +1.4% 94.7-99.6%
12-14 23 98.7 +2.8% 86.7-99.9%
Pocius, Goldberg et al. Contraception 2017
Others:1. Persistent gestational sac: decline, 41% day 3, 74% day 5, 79% day 72. Ectopic: decline, 0.4% day 3, increase 17% day 5
With complete abortion
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hCG trend in ectopic pregnancy
Barnhart, NEJM 2009
Ectopic pregnancies
Most patients have slow rise or flat hcg
Some have slowly declining hcg
When declining, none of the ectopics had > 50% decline within 48 hours
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SummaryOffering same-day start of medication abortion to women with pregnancy of unknown location is a reasonable clinical option:
– Low risk of ectopic pregnancy– Close follow-up to exclude ectopic pregnancy
More research needed − Same-day start with simultaneous testing r/o ectopic
versus delay-for-diagnosis
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Case• Patient 34 d amenorrhea, thickened stripe, no symptoms• No history of tubal surgery, no IUD in situ, no prior ectopic• States she understands risk of ectopic and agrees to close
follow-up• You give patient mifepristone in clinic, misoprostol to take
home and draw her blood for serum hcg.– Serum hcg = 732 (returns after she leaves)
• She takes misoprostol 24h later• Thinks she passed the pregnancy and feels well• Goes to local lab for serum hCG 48h after misoprostol
– Serum hcg (day 4) = 146 (80% decline)
• Done!
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Thank You
Questions?